Draping procedures create an area of asepsis called a sterile field. All sterile items that come into contact with the prepared area about the wound must be restricted within a defined area of safety to prevent transportation of microorganisms into the open wound. The sterile field is created by placement of sterile sheets and towels, or other draping materials, in a specific position to maintain the sterility of surfaces on which sterile instruments and gloved hands may be placed. The patient and operating room table are covered with sterile drapes in a manner which exposes the prepared site of incision and isolates the area of the surgical wound. Objects draped often include instrument tables, basin and Mayo stands, trays, and some surgical equipment.
Draping materials are selected to create and maintain an effective barrier that minimizes the passage of microorganisms between non-sterile and sterile areas. To be effective, a barrier material should be resistant to blood, aqueous fluid, and abrasion, as lint-free as possible, and drapable. It should maintain an isothermic environment that is appropriate to body temperature. It should meet or exceed the requirements of the current National Fire Protection Standards, so no risk from a static charge exists. Alexander's Care of the Patient in Surgery, eds. M. H. Meeker, R.N., et al., 10th edition (Mosby St. Louis, Mo. 1995).
Drapes covering a surface are only considered to be sterile on the side of the drape away from the surface. The portions of the drape hanging down and away from the draped object or person are not considered sterile, since the range of human vision cannot always be counted on to notice breaks in technique and resulting contamination of the drape. p. 117, G. D. LeMaitre, M. D., et al., The Patient in Surgery: A Guide for Nurses, 3rd edition (W. B. Saunders Co. Philadelphia 1975).
Neurosurgical tables currently in use are normally located over and slightly above the person on whom the operation is to be performed. The table is usually prepared for the surgical procedure by the placement of one or more drapes, each for a specific purpose, in order to cover the non-sterile table and areas surrounding the head of the patient.
The anesthesiologist in a neurosurgical operation is usually seated to one side or the other of the operating table. It is desirable for the anesthesiologist to observe the face of the patient and the breathing apparatus connected to the patient to properly assess the patient's condition throughout the surgical procedure. Currently, in order to observe the face of the patient, the anesthesiologist either lifts up a corner of the drape, or attaches the drape to an intravenous bottle standpole, so that the face of the patient may be continuously observed. Obviously this presents problems of contamination, as the sterile field is compromised. Furthermore, neurosurgical operations are very long procedures, in which surgeons sit down for portions of time in wheeled chairs, or move about the head area of the patient. Current drapes trail onto the floor, creating accident hazards for operating room personnel as they walk about the table, as well compromising the sterility of the drape.
Electric cords and suction lines running along the patient to the head area are usually clamped or tied to the edges of the outer sheet on the table. These cords or lines can become tangled, and when pulled may cause devices to fall to the floor and become unsterile. This represents a risk to the patient while under a general anesthesia for the period of time required for the preparation of new sterile devices. Furthermore, the clamps and ties are usually not versatile or strong enough to allow easy addition or removal of tubes and electrical lines. This results in delay in surgery while operating room personnel undo and re-affix clamps.
Therefore, it is an object of the present invention to provide a drape where the face of the patient may be observed directly by the anesthesiologist without compromising the sterile field.
It is another object of the invention to provide a drape which does not trail on the floor of the operating room.
It is a further object of the invention to provide clamps on a drape which are strong and easily adjusted.